Ventavis is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III or IV symptoms. In controlled trials, it improved a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration (see CLINICAL PHARMACOLOGY, Clinical Trials).

Ventavis is intended to be inhaled using either of two pulmonary drug delivery devices: the I-neb™ AAD® System or the Prodose® AAD® System. The first inhaled dose should be 2.5 mcg (as delivered at the mouthpiece). If this dose is well tolerated, dosing should be increased to 5.0 mcg and maintained at that dose; otherwise maintain the dose at 2.5 mcg. Ventavis should be taken 6 to 9 times per day (no more than once every 2 hours) during waking hours, according to individual need and tolerability. The maximum daily dose evaluated in clinical studies was 45 mcg (5 mcg 9 times per day).

Direct mixing of Ventavis with other medications in the I-neb™ AAD® System or the Prodose® AAD® System has not been evaluated. To avoid potential interruptions in drug delivery due to equipment malfunctions, the patient should have easy access to a back-up I-neb™ AAD® System or the Prodose® AAD® System.

Ventavis is supplied in two ampule configurations, a 2mL and a 1mL single-use glass ampule. Both ampule sizes contain 10 mcg/1mL.

The 2mL single-use ampule delivers 20 mcg to the medication chamber of either of the AAD® Delivery Systems. The 2mL must be used with the Prodose® AAD® System and may be used with the I-neb™ AAD® System.

The 1 mL ampule delivers 10 mcg to the medication chamber and must only be used with the I-neb™ AAD® System.

Both the 2mL and the 1 mL ampules deliver a nominal dose of either 2.5 mcg or 5.0 mcg at the mouthpiece of the AAD® Delivery System for which they are labeled for use.

Each inhalation treatment requires one single-use ampule.

For each inhalation session, the entire contents of one opened ampule of Ventavis should be transferred into either the I-neb™ AAD® System or the Prodose® AAD® System medication chamber (2 mL ampule only) immediately before use. After each inhalation session, any solution remaining in the medication chamber should be discarded. Use of the remaining solution will result in unpredictable dosing. Patients should follow the manufacturer's instructions for cleaning the I-neb™ AAD® System or the Prodose® AAD® System components after each dose administration.

Preparation

1. With one hand, hold the bottom of the ampule with the blue dot facing away from your body.
2. With the other hand, wrap the included rubber pad round the entire ampule.
3. Using your thumbs, break open the neck of the ampule by snapping the top towards you.
4. Using the small tube (pipette) supplied with Ventavis, draw-up the entire amount of one ampule of Ventavis and transfer the entire contents of the ampule into the medication chamber of either the I-neb™ AAD® System or the Prodose® AAD® System.
5. Safely dispose of the open ampule and pipette as instructed by your healthcare practitioner. Keep ampules and pipettes out of the reach of children.
6. Follow the instructions provided by the drug manufacturer for administration of the Ventavis dose and maintenance of the I-neb™ AAD® System or the Prodose® AAD® System.

Should patients deteriorate on this treatment, alternative treatments should be considered. Several patients whose status deteriorated while on Ventavis were successfully switched to intravenous epoprostenol.

Dosage and Administration in Hepatic Impairment

Because iloprost elimination is reduced in patients with impaired liver function (see CLINICAL PHARMACOLOGY and PRECAUTIONS), caution should be exercised during iloprost therapy in patients with at least Child Pugh Class B hepatic impairment.

Dosage and Administration in Renal Impairment

Dose adjustment is not required in patients not on dialysis. The effect of dialysis on iloprost is unknown. Use caution in treating patients on dialysis (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

Ventavis (iloprost) Inhalation Solution is supplied in two ampule. configurations , 2 mL and 1mL:

For the 2mL ampule Ventavis is supplied in cartons of 30 clear glass single-use ampules (20 mcg iloprost per 2mL ampule):

30 single-use ampule cartons: NDC 10148-101-30

For the 1 mL ampule Ventavis is supplied in cartons of 30 clear glass single-use ampules (10 mcg iloprost per1mL ampule):

30 single-use ampule cartons: NDC 66215-302-30

Storage

Store at 20 – 25°C (68 – 77°F)

Excursions permitted to 15 – 30°C (59 – 86°F)

[See USP Controlled Room Temperature]

Distributed by: Actelion Pharmaceuticals US, Inc. 5000 Shoreline Court, Ste. 101 South San Francisco, CA 94080. January 2008. FDA rev date: 3/4/2008

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